Therapeutic Goods Administration

The Therapeutic Goods Administration (TGA) is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia.^[1] It is a Division of the Australian Department of Health established under the Therapeutic Goods Act 1989 (Cth).^[2][3] The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.

TGA Expert Advisory Committees

The TGA has nine statutory expert committees it may call upon to obtain independent advice on scientific and technical matters, including:

• Advisory Committee on Biologicals (ACB)
• Advisory Committee on Complementary Medicines (ACCM)
• Advisory Committee on Medical Devices (ACMD)
• Advisory Committee on Non-prescription Medicines (ACNM)
• Advisory Committee on Prescription Medicines (ACPM)
• Advisory Committee on the Safety of Medical Devices (ACSMD)
• Advisory Committee on the Safety of Medicines (ACSOM)
• Advisory Committee on the Safety of Vaccines (ACSOV)
• Therapeutic Goods Committee (TGC) – advises the Minister on standards for therapeutic goods, including labelling and packaging, and on principles to be observed in the manufacture of therapeutic goods for use in humans.

Trans-Tasman harmonisation

The governments of Australia and New Zealand were working towards establishing a Trans-Tasman joint agency for the regulation of drugs and therapeutic goods to replace the TGA and New Zealand's Medsafe. However, on 16 July 2007, the New Zealand State Services Minister Annette King announced that "The Government is not proceeding at this stage with legislation that would have enabled the establishment of a joint agency with Australia to regulate therapeutic products". She further advised that "The [New Zealand] Government does not have the numbers in Parliament to put in place a sensible, acceptable compromise that would satisfy all parties at this time. The Australian Government has been informed of the situation and agrees that suspending negotiations on the joint authority is a sensible course of action". Further details are available at the Australia New Zealand Therapeutic Products Authority (ANZTPA) website.

See also

• Australian Competition and Consumer Commission
• Australia New Zealand Therapeutic Products Authority
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• List of Australian Commonwealth Government entities
• Standard for the Uniform Scheduling of Drugs and Poisons

References

1. "About the TGA". Department of Health Therapeutic Goods Administration.
2. "About the Australina therapeutic goods legislation". Department of Health Therapeutic Goods Administration.
3. Therapeutic Goods Act 1999 (Cth)

External links

• TGA website
• Therapeutic Goods Act 1989
• New AU eCTD Guidance
• Australia Re-Releases M1 Guidance for CTD
• Articles by Australian's IT Scientist's for the TGA